Phase I/II Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of TQB3126 in Subjects With Breast Cancer
The study includes Phase I dose escalation and expansion and Phase II combination therapy. It uses a multicenter, open-label, non-randomized design to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of TQB3126 in breast cancer. Phase I dose escalation uses a Rolling 6 design after accelerated titration at the first dose, with dose decisions reviewed by the Safety Review Committee. Dose expansion includes two cohorts of approximately 20-60 participants each. The study also explores relationships between drug exposure and efficacy/safety, including concentration-QTc assessment using Holter electrocardiograms.
• Subjects voluntarily participate in this study, sign the informed consent form, and demonstrate good treatment compliance.
• Aged 18 to 75 years at the time of informed consent signature; Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 or 1; estimated survival expectancy of more than 3 months.
• Histopathologically confirmed breast cancer.
• Documented disease progression confirmed by clinical or imaging evidence during or after the most recent prior systemic therapy prior to the first study drug administration.
• Have evaluable lesions per RECIST v1.1 criteria (measurable lesions; or bone-only metastases with at least one osteolytic or mixed lesion).
• Adequate tissue samples shall be provided at screening for gene mutation testing to clarify genetic status.
• Laboratory test results meet the criteria specified in the protocol (blood routine, liver and renal function, coagulation function, cardiac ultrasound Left Ventricular Ejection Fraction(LVEF) and other indicators are all within the protocol-specified ranges).
• Subjects of childbearing potential must agree to use effective contraceptive measures throughout the study and for 6 months after study completion (the same requirement applies to male subjects); serum or urine pregnancy test result is negative within 7 days prior to enrollment.